Case study: Monitoring patients taking nitrofurantoin for potential lung disease

Through its core work to review recorded patient safety events, the National Patient Safety Team identified an issue where a patient developed lung disease following long term treatment with nitrofurantoin, an antibiotic used to treat urinary tract infections.

Working jointly with the NHS England Antimicrobial Resistance Team, we asked the Medicines and Healthcare products Regulatory Agency (MHRA) for the manufacturers’ information relating to monitoring of patients taking nitrofurantoin to be improved.

As a result, the wording of the Summary of Product Information (SPC) and Patient Information Leaflets (PILs) will be strengthened to emphasise the need for vigilance of emerging respiratory symptoms during treatment with nitrofurantoin and to ensure that these warnings are prominent.  These updates have been communicated to healthcare professionals via the MHRA’s Drug Safety Update Bulletin.

About our patient safety review and response work

The recording and central collection of patient safety events to support learning and improvement is fundamental to improving patient safety across all parts of NHS healthcare. The National Patient Safety Team identify new or under recognised patient safety risks, which are often not obvious at a local level. It does this through its core work to review patients safety events recorded on national systems, such as the National Reporting and Learning System (NRLS), the new Learn from Patient Safety Events service (LFPSE), and other sources.

In response to any newly identified risks, we develop advice and guidance, such as National Patient Safety Alerts, or work directly with partners as in the example above, to support providers across the NHS to take the necessary action to keep patients safe.

You can find out more about our processes for identifying new and under recognised patient safety issues on our using patient safety events data to keep patients safe and reviewing patient safety events and developing advice and guidance web pages.

You can also find more case studies providing examples of this work on our case study page.